Viewing Study NCT02558660


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Study NCT ID: NCT02558660
Status: COMPLETED
Last Update Posted: 2015-12-28
First Post: 2015-09-04
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Evaluating Use of a Farmers Market Incentive Program Among Low-Income Health Center Patients
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-24', 'studyFirstSubmitDate': '2015-09-04', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2015-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of participant DUFB use over time, as assessed by an interviewer-administered survey using structured open-ended questions', 'timeFrame': '5 months', 'description': 'Use of DUFB at baseline assessed with yes/no response. At each of the the 3 follow-up surveys waves (1.5 months, 3 months, and 5 months), participants will be asked if they have used DUFB in the past month (yes/no), and if yes, how many times.'}, {'measure': 'Participant-perceived barriers and facilitators to DUFB use following educational intervention, as assessed by an interviewer-administered survey using structured open-ended questions and semi-structured focus group questions', 'timeFrame': '12 months', 'description': 'Through an iterative process, three team members will independently conduct thematic analyses, compared codes, resolve discrepancies, and summarize key thematic findings.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline fruit and vegetable consumption at 1.5 months, 3 months, and 5 months, as assessed by a validated 2 question fruit and vegetable screener', 'timeFrame': 'baseline, 1.5 months, 3 months, 5 months', 'description': 'Servings/day range from 0 to \\>=4 (scale applied separately to fruit consumption and vegetable consumption. Change will be calculated from two time points at each of three follow-up periods (1.5 months, 3 months, and 5 months) minus the baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Supplemental Nutrition Incentive Program (SNAP)', 'economic incentive'], 'conditions': ['Food Insecurity', 'Non-use of Existing State-wide SNAP Incentive Program']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of a brief clinic-based educational intervention on utilization of Double Up Food Bucks (DUFB)-a Michigan-wide Supplemental Nutrition Assistance Program (SNAP) healthy food incentive--among low income health center patients at a community health center in Southeast Michigan.', 'detailedDescription': 'Study participants were provided a 3-5 minute explanation of DUFB, written program materials, and initial $10 market voucher. Participants were surveyed four times over five months, and a subset are also participating in post-intervention focus groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient or family member of patient\n* at least 18 years of age\n* currently SNAP-enrolled\n* identifies as one of primary food shoppers for household\n* English or Spanish-speaking\n\nExclusion Criteria:\n\n* under 18\n* not currently SNAP-enrolled\n* not one of primary food shoppers for household\n* unable to complete a telephone survey in English or Spanish\n* unable to provide a working telephone number where they could be contacted'}, 'identificationModule': {'nctId': 'NCT02558660', 'briefTitle': 'Evaluating Use of a Farmers Market Incentive Program Among Low-Income Health Center Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Evaluating Use of a Farmers Market Incentive Program Among Low-Income Health Center Patients', 'orgStudyIdInfo': {'id': 'HUM00076630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double Up Food Bucks', 'description': 'Clinic-based educational intervention about an existing SNAP healthy food incentive program, as well as a $10 voucher to spend on produce at farmers markets', 'interventionNames': ['Behavioral: Education', 'Behavioral: voucher']}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Educational intervention about an existing SNAP healthy food incentive program', 'armGroupLabels': ['Double Up Food Bucks']}, {'name': 'voucher', 'type': 'BEHAVIORAL', 'description': '$10 voucher to spend on produce at farmers markets', 'armGroupLabels': ['Double Up Food Bucks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48198', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ypsilanti Health Center, University of Michigan', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}], 'overallOfficials': [{'name': 'Alicia Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer, Robert Wood Johnson Foundation Clinical Scholar', 'investigatorFullName': 'Alicia Cohen', 'investigatorAffiliation': 'University of Michigan'}}}}